FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
136657–136680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1988
TRACKER-25 INFUSION CATHETER
K874751 · DQY
Target Therapeutics
Cardiovascular · 86d
Cleared Feb 12, 1988
C900 X-RAY FILM PROCESSOR
K874908 · IXW
Summit Industries, Inc.
Radiology · 73d
Cleared Feb 12, 1988
MODEL 8800 CARDIORESPIRATORY OXIMETER
K874947 · DQA
Nonin Medical, Inc.
Anesthesiology · 72d
Cleared Feb 12, 1988
BIOSURGE MODEL OASYS-II
K875023 · CAC
Biosurge, Inc.
Anesthesiology · 70d
Cleared Feb 12, 1988
OXYGEN/PULSE MONITOR
K875031 · DQA
Healthdyne, Inc.
Anesthesiology · 67d
Cleared Feb 12, 1988
STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407
K875058 · BSY
Busse Hospital Disposables, Inc.
Anesthesiology · 65d
Cleared Feb 12, 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K875059 · LDF
Daig Corp.
Cardiovascular · 65d
Cleared Feb 12, 1988
ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE
K875269 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 52d
Cleared Feb 12, 1988
SHIMADZU CATHETERIZATION C-ARM STAND ER-200
K875372 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20
K875373 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CEILING-SUSPENDED C-ARM CH-50
K875374 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU LATERAL C-ARM MH-30
K875375 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-50B
K875376 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU MAMMOGRAPHIC STAND MR-30
K875377 · IZH
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A
K875379 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-10
K875380 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K880247 · BTO
Shiley, Inc.
Anesthesiology · 23d
Cleared Feb 12, 1988
MOBILE PAK, MODEL AC
K880261 · CAW
Intl. Biomedical Concepts, Inc.
Anesthesiology · 21d
Cleared Feb 12, 1988
MOBILE PAK, MODEL DC
K880262 · CAW
Intl. Biomedical Concepts, Inc.
Anesthesiology · 21d
Cleared Feb 11, 1988
MODEL 820 TOP=TRAK
K873039 · BYN
Sierra Laboratories, Inc.
Anesthesiology · 191d
Cleared Feb 11, 1988
WAKO(TM) PRETEST 6A
K873409 · KHE
Wako Chemicals USA, Inc.
Chemistry · 170d
Cleared Feb 11, 1988
MENTOR BLACK LIGHT URETERAL STENT SET
K873557 · FAD
Mentor Corp.
Gastroenterology & Urology · 161d
Cleared Feb 11, 1988
MASK, OXYGEN
K874092 · BYG
Life Support Products, Inc.
Anesthesiology · 126d
Cleared Feb 11, 1988
VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER
K874112 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 125d